MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-21 for HTR POLYMER IMPLANT PM617983 manufactured by Biomet Microfixation.
[48252966]
Notified today (b)(6) 2016 of an urgent product recall by biomet microfixation involving the hard tissue replacement polymer implants. In reviewing our records, we had 2 of the recalled items at our facility. One not implanted and returned to company. The other implanted in pt named in this form.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063013 |
| MDR Report Key | 5748395 |
| Date Received | 2016-06-21 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-06-13 |
| Date Added to Maude | 2016-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HTR POLYMER IMPLANT |
| Generic Name | HTR POLYMER IMPLANT |
| Product Code | KRR |
| Date Received | 2016-06-21 |
| Model Number | PM617983 |
| Lot Number | 682030 |
| Device Expiration Date | 2019-09-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-21 |